This invention relates generally to an endocervical curette or endocervical scraper, for use both in detecting cervical cancer beyond the site of the colposcope and in all endoscopic examinations.
Detection of the cervix area for abnormal cell growth ranging from precancerous atypical dysplasia to invasive cancer is begun by first obtaining a pap smear of the area. It is paranthetically noted that the discussion herein relates to carcinoma or dysplasia only of the endocervix area and is generally not directed to diagnosis of cells of the vagina and vulva.
The cervix, which is the circular constricted area between the uterus and the vagina, presents particular problems for the gynecologist in the area up to the anatomical internal os, for it is in this area that the gynecologist has difficulty in directly observing even with instrumentation and where biopsy sampling and curettage, that is, gathering of tissue and mucus samples, is most problematical.
Upon information of a positive, or abnormal, pap smear, certain procedures relating to the cervix area of the patient are generally followed by the gynecologist. The procedures mentioned are as follows: observing the cervix with a magnifying colposcope, which makes suspicious areas in the transitional zone obvious to the physician; taking a biopsy of the suspicious areas with a fine instrument either as directed by the colposcope, or, if the upper areas of the cervix at or beyond the internal os are involved, taking the biopsy blindly; making an endocervical curettage (ECC) with a curette around the entire area of the cervix, up to the internal anatomical os. A pathologist examines the biopsied and curettaged samples to determine how atypical the cell samples are, that is, whether the cells reveal dysplasia, surface cancer (intraepithetial neoplasia, cin I, II, or III, or invasive cancer. With this information, the gynecologist proceeds with the proper treatment directed to removal of the abnormal cells.
The curettes used in the field for taking the curetted samples are the metal "G" curette and the "K" curette. These are illustrated in FIGS. 11 and 12 respectively and are discussed briefly in the detailed discussion below. Neither type of curette, in my opinion, possesses the structure that enables a gynecologist to ensure that an adequate curetted sample is obtained for the pathologist. This structural inadequacy lends itself, I believe, to small inaccuracies in the sampling procedure. The G curette forces the colopscopist to push and probe tissue from its crevices, and the K curette may miss a small strip of cells that could possibly include invasive cancer. The K curette also requires shaking tissue from the curette into the specimen bottle, which contains a fixative such as formaldahyde. Care must be taken that all the tissue and mucus taken from the endocervix during the ECC is shaken from the curette into the fixative. Both the G and K curettes also require a vaginal non-absorbent posterior sponge for mucus that may contain abnormal cells.
The ECC procedure is very important because the colposcopic examination is incomplete since approximately 14% of lesions picked up by the pap smear occur up to the internal os area, beyond the area seen in a colposcopic examination. There is a 5% reoccurrence of cancer after local treatment. This reoccurrence can be reduced to 0% if a curette can be devised that eliminates the inadequacies and inaccuracies of the presently used curettes.
It is noted that another difficulty in using present curettes is that every cervix differs in size according to age, the number of births, or menopausal situation, for example. Missing an invasive cervical cancer is a disaster: in six months an invasive cancer can progress rapidly.
It is very important that the gynecologist give the pathologist every iota of material to make possible a correct diagnosis for relatively hidden or obscure areas so that the patient is not subjected to a cone biopsy, which is extremely dangerous both at the time and in future reproductive years when, among other problems, mid-trimester abortions occur. Early dysplasia and/or carcinoma occurs even in girls 14 to 16 years of age, so every means should be taken to arrest this slow-moving disease before it becomes invasive. Once invasive, the consequences are devastating. Radiation therapy or radical surgery, even if successful in stopping the cancer, can still leave young women sexually crippled and/or sterile.
Accordingly, it is an object of the present invention to provide a disposable curette for performing an ECC that is superior to curettes known in the art.
It is a further object of the present invention to provide a disposable curette for an ECC that is capable of obtaining a complete tissue and mucus sample from the area of the cervix up to the internal os where viewing by the colposcope is impossible and tissue and/or mucus samples are not practically obtainable by currettage plus vaginal sponge or telfa placed posteriorly in the vagina.
It is still another object of the present invention to provide a disposable, non-absorbable curette for an ECC that can be removed from a handle and placed in toto in a jar of fixative with the biopsied material and non-absorbably pad, wasting no time and requiring little or no effort by the operator.
It is yet another object of the present invention to provide a removable curette for an ECC that is capable of scraping a complete or an almost complete revolution of the cervix in the area of the endocervix up to the internal os and placed in a fixative in toto.
It is yet another object of the present invention to provide a disposable curette for an ECC that is capable of providing a complete tissue and mucus sample by successive scrapings of removable curettes so that the total sample contains all areas of potential abnormal cells so that the pathologist is assured of having every sample of suspect tissue and mucus so that the chance of error is reduced to virtually or absolutely nil.
In order to achieve the above objects, as well as others that will become apparent hereafter, a curette apparatus is provided for scraping the cervix area of a patient in an endocervical curretage (ECC) procedure that includes an elongated handle member having a gripping and an opposed mounting end; a curette member removably connected to the mounting end of the handle member; and a locking apparatus for removably holding the curette member to the mounting end of the handle member in a captured position. The curette member is adapted to scrape tissue and mucus from the surface of the endocervix, up to the area of the internal os, and is also adapted to hold removed tissue and mucus upon removal of the curette member from the handle member.
The curette member includes an elongated wall having a curved base edge having base ends, a tip portion, and a pair of mating inwardly tapered edges extending between the base ends and the tip portion. The curved base wall is preferably formed over a 140.degree. arc. The elongated wall includes an inner surface defining a hollow between the tapered edges and the base edge. A base wall having a flat top surface generally transverse to the elongated wall is secured to the curved base edge of the elongated wall, the base wall further defining the hollow. The base wall has an edge portion that is preferably circular and the base ends of the elongated wall of the curette member is generally coextensive with the edge portion. The elongated wall and the tapered edges define a slight curvature adapted to fit generally over the surface of the endocervix to the internal os. The curvature will vary according to a range of patterns that relate to different sizes and configurations of the cervixes of women of varying ages, sizes and conditions. The curvature is tilted inward, or toward, the hollow and the base wall.
The inner surface of the curette member forms a plurality of serrations at the tapered edges of the curette member; the serrations are slightly spaced from the tapered edges and lie generally on the inner side of the hollow formed by the inner surface. The serrations are adapted to move smoothly over the surface of the deep endocervix when the curette is moved inwardly into the cervix; to collect tissue and mucus when the curette member is firmly pressed against the endocervical tissue and pulled outwardly from the internal os to the ectocervix so as to remove a scraping and to prevent loss of even a single malignant focus of cells.
The locking apparatus includes a male member positioned at the mounting end of the handle member, and a female housing forming a locking chamber and extending from the base wall of the curette member. The female housing is capable of movement between open and closed positons wherein in the open position the male member is capable of movement into or from the chamber and in the closed position the male member is axially locked in the captured position. The female housing includes a cylindrical side wall extending downwardly from the rim of the circular base wall. The housing has a cylindrical side wall that comprises a pair of opposed half side walls that are joined at a diametrical groove formed across the top surface of the base wall. The half side walls are biasable apart to a distance that enables the male member to pass into or from the chamber. A circular tab that extends radially inward from the bottom rim of the cylindrical side wall is adapted to fit into a radial circular pocket formed by the male member. A pair of opposed dowels connected to the inner surface of each of the cylindrical half walls of the female housing extend transversely into the locking chamber and are adapted to fit into a pair of opposed axially aligned tracking slots formed in the male member that lead to a radial locking slot that has outer and inner slot portions joined by a slanted surface. When the dowels are at the outer slot portions and the male member and the female housing are rotated relative to one another, the dowels are moved in the slot to the inner slot portion so as to radially lock the male member with the female member and the curette member to the handle. The female housing is self-biased at the base wall so as to bias the two half side walls together.
The present invention will be better understood and the objects and important features, other than those specifically set forth above, will become apparent when consideration is given to the following details and description, which when taken in conjunction with the annexed drawings, describes, discloses, illustrates, and shows preferred embodiments or modifications of the present invention and what is presently considered and believed to be the best mode of practice in the principles thereof. Other embodiments or modifications may be suggested to those having the benefit of the teachings herein, and such other embodiments or modifications are intended to be reserved especially as they fall within the scope and spirit of the subjoined claims.